Manufacturing Associate, CAR-T Abecma CAR-T

Manufacturing Associate, CAR-T, Manufacturing Operations

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Purpose and Scope of Position:
Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Shift Available:
Wednesday
- Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m.

- 5:30 a.m.

Times are subject to change based on business demands.

Responsibilities:

• Manufacture human blood-derived cellular therapy products in accordance with SOPs and cGMP requirements.
• Perform cell culture maintenance and expansion, cell harvest, isolation and cryopreservation activities.
• Execute aseptic processing activities, including:
  • Tube welding
  • Sampling
  • Cell counts
  • Sterile connections
  • Material transfers
• Weigh and measure in-process materials to ensure required quantities are added or removed.
• Adhere to production schedules and support on-time manufacturing operations.
• Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Communicate production deviations and support quality investigations when required.
• Work collaboratively within a cross-functional, team-based manufacturing environment.
• Perform activities within a designated manufacturing function as assigned.
• Perform additional manufacturing-related tasks as directed by management.
• Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintains timing according to the production schedule to ensure on-time logistics.
• Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Works in a team based, cross-functional environment to complete tasks required by shift schedule.
• Available to work OT when business requires.
• Willing to work staggered day shift hours.
• Records patient material handling data and information in a clear, concise, format according to proper GDPs.

Knowledge and Skills

• Basic understanding of:
  • Cell culture
  • Cryopreservation
  • Cell Expansion
  • Aseptic processing techniques
  • Laboratory techniques
• Knowledge and understanding of cGMP and FDA-regulated manufacturing environments.
• Technical writing and documentation skills.
• Proficiency in Microsoft Office applications.
• Foundational knowledge of:
  • Biology
  • Chemistry
  • Mathematics
• Strong teamwork and communication skills.
• Ability to work effectively in a fast-paced manufacturing environment.
• Inventory control and/or management.

Minimum Requirements

Education and Experience

• Bachelor's Degree; OR
• Associate degree/Medical Technical Degree with at least 2 years of manufacturing or operations experience; OR
• High School Diploma/GED with at least 4 years of manufacturing or operations experience.

Working Conditions:

• Work within a controlled cGMP cleanroom environment.
• Routine exposure to human blood components.
• Required to wear cleanroom garments and personal protective equipment (PPE), including coverings for:
  • Head
  • Face (partial)
  • Body
  • Legs and feet
• Work in enclosed, restricted cleanroom areas with controlled pressure and temperature.
• Exposure to:
  • Reagents
  • Manufacturing chemicals
  • Sanitization agents
• Must comply with cleanroom restrictions, including prohibition of:
  • Makeup
  • Gum
  • Nail polish
  • Personal electronic devices in designated areas
• Ability to stand or sit for extended periods.
• Frequent walking and movement throughout the manufacturing area.
• Ability to use computers and complete documentation tasks.
• Ability to lift up to 25 pounds.
• Must possess sufficient vision and hearing to perform job duties safely.
• Must be flexible with production schedules, including weekend shifts and potential schedule changes based on business needs.

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